MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SMART COIL; HCG, KRD

Catalog Number	400SMTHXSFT0102
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal iliac artery (iia) using a penumbra smart coil (smart coil), a penumbra smart coil detachment handle (handle), and a non-penumbra microcatheter.It was noted that the patient¿s anatomy was moderately tortuous.During the procedure, the physician advanced the smart coil into the target vessel using the microcatheter, then attempted to detach it using the handle.However, the smart coil failed to detach.After multiple failed attempts to detach the smart coil using the handle, the physician decided to remove the smart coil.While retracting the smart coil, it unintentionally detached within the microcatheter.Therefore, the microcatheter containing the smart coil was removed and the coil was flushed out.The procedure was completed using two new smart coils, a new handle, and four non-penumbra coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned smart coil revealed that the pet lock was separated on the proximal end of the pusher assembly, and the pull wire was retracted from its original position on the distal tip of the pusher assembly.This typically occurs during a successful embolization coil detachment.Based on the returned condition, the root cause of the reported complaint could not be determined.Further evaluation revealed multiple kinks along the length of the pusher assembly.This damage was incidental to the reported complaint and may have occurred during packaging of the device for return to penumbra.Penumbra products are visually inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 17275036
• Report Number: 3005168196-2023-00321
• Device Sequence Number: 14748645
• Product Code: HCG
• UDI-Device Identifier: 00814548015613
• UDI-Public: 814548015613
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/06/2023
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/17/2026
• Device Catalogue Number: 400SMTHXSFT0102
• Device Lot Number: F106345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2023
• Initial Report FDA Received Date: 07/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/01/2005